BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K021630
Device Name BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
Original Applicant
BOSTON SCIENTIFIC CORP.
one scimed place
maple grove, 
MN 
55311 -1566

Original Contact todd kornmann
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 05/17/2002
Decision Date 10/25/2002
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No